US9114021B2 - Method for providing disc nucleus replacement in a spine - Google Patents
Method for providing disc nucleus replacement in a spine Download PDFInfo
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- US9114021B2 US9114021B2 US13/653,004 US201213653004A US9114021B2 US 9114021 B2 US9114021 B2 US 9114021B2 US 201213653004 A US201213653004 A US 201213653004A US 9114021 B2 US9114021 B2 US 9114021B2
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- interbody device
- vertebrae
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- core
- spine
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Definitions
- the present invention relates to fusion and non-fusion spinal interbody devices.
- the present invention answers this need by providing an interbody device with both rigid and compressible components for both supporting and absorbing axial loads while limiting subsidence and endplate erosion.
- the compressible components include material of greater compressibility than material of rigid components.
- rigid material may include, but is not limited to, biocompatible materials such as polyetheretherketone (PEEK), carbon fiber reinforced PEEK such as PEEK-Optima (Invibio, Inc., West Conshohocken, Pa.) and other biocompatible polymeric materials.
- PEEK polyetheretherketone
- rigid material may include biocompatible metals, including without limitation titanium, stainless steel and cobalt chromium alone or in combination with other materials.
- the compressible material may include, but not limited to, biocompatible materials such as elastomers, thermoplastic polyurethane elastomers such as Tecothane (Lubrizol Advanced Materials Inc., Wickliffe, Ohio), ultra high molecular weight polyethylene (UHMWPE), polycarbonate urethane (Sulene-PCU), polyethylene terephtalate (Sulene-PET), hydrogels (including with a polyethylene jacket), polyvinyl alcohol hydrogel (Aquarelle) and polycarbonate urethane elastomer (Newcleus) alone or in combination with other materials.
- biocompatible materials such as elastomers, thermoplastic polyurethane elastomers such as Tecothane (Lubrizol Advanced Materials Inc., Wickliffe, Ohio), ultra high molecular weight polyethylene (UHMWPE), polycarbonate urethane (Sulene-PCU), polyethylene terephtalate (Sulene-PET), hydrogels
- an interbody device includes top and bottom shells of a first material and an inner dampener of second dampening material.
- top and bottom shells comprise a carbon fiber reinforced PEEK material and the inner dampener material of a thermoplastic polyurethane elastomer.
- a plurality of shell components may be coupled with an inner dampener material.
- an inner dampener may comprise a mechanical spring and like compressible components of various materials.
- an interbody device of the invention may be an ellipsoid, including but not limited to a sphere, oblate spheroid, prolate spheroid and scalene ellipsoids.
- an interbody device may compromise a partial ellipsoid, partial polyhedrons and other shapes configured to include top and bottom curved surface portions for contacting vertebral bodies.
- an interbody device includes an inner dampener having one or more ellipsoidal compressible core portions and a compressible equatorial planar surface portion extending outwardly from the core.
- a pillar support may extend outward from one or more ellipsoidal core portions of the inner dampener.
- one or more pillar supports may include a head with a larger diameter than a pillar, wherein the head couples within a complimentary receiving portion of an outer shell such that one or more heads secure the inner dampeners and its components, such as an equatorial planar surface portion, one or more compressible ellipsoidal core portions and one or more pillars, within the inner body device.
- compressible and rigid materials may be combined through coupling means including, but not limited to, molding including overmolding and injection molding, press-fitting, adhesives, mechanical fastening and the like.
- an interbody device of the present invention may be adapted for interbody fusion procedures to provide improved stabilization, stress-shielding and maintenance of placement in the interbody space.
- an interbody device of the present invention may be adapted for interbody non-fusion procedures to provide dynamic stabilization, stress-shielding, reduced movement, reduced likelihood of escape and reduced subsidence.
- FIG. 1 is a front plan view of a spherical interbody device in one embodiment of the present invention.
- FIG. 2 is a top plan view plan view of a spherical interbody device in one embodiment of the present invention.
- FIG. 3 is a bottom plan view of a spherical interbody device in one embodiment of the present invention.
- FIG. 4 is a front perspective view of a spherical interbody device in one embodiment of the present invention.
- FIG. 5 a cross-sectional perspective view along Section A-A of FIG. 1 in one embodiment of the present invention.
- FIG. 6 is a cross-sectional perspective view along Section B-B of FIG. 1 in one embodiment of the present invention.
- FIG. 7 is a cross-sectional perspective view along Section C-C of FIG. 1 in one embodiment of the present invention.
- FIG. 8 is an exploded view of a spherical interbody device in one embodiment of the present invention.
- FIG. 9 is a bottom plan view of top outer shell of a spherical interbody device in one embodiment of the present invention.
- FIG. 10 is a front plan view of an inner dampener of a spherical interbody device in one embodiment of the present invention.
- FIG. 11 is a perspective view of an inner dampener of a spherical interbody device in one embodiment of the present invention.
- the present invention provides an apparatus for disc nucleus replacement to promote the support and absorption of axial loads while limiting subsidence and endplate erosion in both vertebral fusion and non-fusion spinal treatments.
- the combination of rigid and compressible components with curved surface portions, including a smooth outer surface in embodiments is adapted for placement and contacting the vertebral bodies to promote motion preservation and dynamic stabilization.
- an interbody device 10 of the invention in various embodiments supports spinal loads of preferably over 700 pounds and up to 1000 pounds without damage or disadvantageous alteration of the interbody device 10 .
- an interbody device 10 in one embodiment of the invention is a spherical shape.
- the device 10 includes a top outer shell 102 , a bottom outer shell 104 and an inner dampener 200 .
- the outer shells 102 and 104 may comprise sphere portions adapted to couple to inner dampener 200 .
- the top outer shell 102 and bottom outer shell 104 may be identical in size and shape. In other embodiments the shells 102 and 104 may be differently sized or shaped.
- the outer shells may comprise relatively rigid biocompatible materials, including, but not limited to, PEEK or carbon fiber reinforced PEEK (such as PEEK-Optima), titanium, stainless steel, cobalt chromium and the like, either alone or in combination with these or other materials.
- the outer shells may include other rigid polymeric materials or other metal materials.
- shells 102 and 104 include a smooth outer surface generally free of a frictional texture and protrusions.
- inner dampener 200 is molded with a rim 210 as an equatorial planar surface portion coupled to convex ellipsoidal compressible core portions 220 .
- a pillar 230 extends to a head 240 .
- each head 240 includes a slanted face 250 of a cylindrical segment of head 240 .
- the rim 210 has a diameter of about 11 mm and is about 2 mm thick.
- the pillar 230 has a diameter of about 1.27 mm and heads 240 have a diameter of about 1.88 mm.
- faces 250 also provide a continuous, smooth outer surface in combination with the outer shells.
- the inner dampener 200 may comprise compressible material including, but not limited to, polyethylene, polycarbonate urethane (Sulene), polyethylene terephtalate (Sulene), HP-100 silicone elastomer, hydrogel with a polyethylene jacket, polyvinyl alcohol hydrogel (Aquarelle), polycarbonate urethane elastomer (Newcleus), thermoplastic polyurethane elastomer (such as Tecothane) or other elastomers, polymers, plastics or rubber-like substances, either alone or in combination with these or other materials.
- compressible material including, but not limited to, polyethylene, polycarbonate urethane (Sulene), polyethylene terephtalate (Sulene), HP-100 silicone elastomer, hydrogel with a polyethylene jacket, polyvinyl alcohol hydrogel (Aquarelle), polycarbonate urethane elastomer (Newcleus), thermoplastic polyurethane elastomer (such as Te
- inner dampener material exhibits the following characteristics: (i) compliant enough to substantially reduce indentation into the vertebrae and (ii) stiff enough to keep an outer shell from breaking.
- an interbody device 10 of the present invention will undergo compressive deformation during daily activities and restore itself to near its original form each day during typical daily rest, including at least 98% daily restoration in one embodiment.
- an interbody device 10 of the present invention includes a creep modulus that changes by less than 20% in ten years at 37° C.
- an interbody device 10 is injection moldable, such as a thermoplastic or thermoset.
- the inner dampener 200 comprises Tecothane brand thermoplastic polyurethane elastomer and the outer shells comprise PEEK-Optima brand carbon fiber reinforced PEEK.
- each of outer shells 102 and 104 include a complimentary internal structure to the inner dampener 200 .
- Two crossing ribs 110 segment the internal structure of an outer shell into four concave seating portions 120 that each seat a convex portion 220 of the inner dampener 200 .
- Each seating portion 120 communicates with walled portion 117 of a cylindrical segment of the opening 115 .
- Walled portion 117 is complimentary to inner dampener heads 240 that fill the opening 115 and the head faces 250 provide portions of the contoured outer surface of the device 10 with outer shells 102 and 104 .
- ribs 110 are about 1.27 mm thick and the outer shells have a thickness of about 2.03 mm.
- cross-sectional views of assembled interbody device 10 depict the internal molding of inner dampener 200 to shells 102 and 104 .
- Circular rim 210 extends through the middle of interbody device 10 along section A-A ( FIG. 5 ) that depicts the center of the interbody device 10 and between segments 220 .
- FIG. 6 shows segments 220 and rim 210 within shells 102 and 104 along section B-B which cross-sections interbody device 10 outward from its center and before pillars 230 and heads 240 .
- section C-C provides a cross-section through two top and two bottom openings 115 moving further outward through the interbody device 10 from sections B-B and A-A.
- rim 210 , convex portions 230 and heads 240 with faces 250 are shown molded within shells 102 and 104 .
- interbody device 10 may have diameters of various sizes, including ranging from about 6 to about 18 mm, although such sizes may be adapted to the particular patient or purpose. In one embodiment, the interbody device has a spherical diameter of about 11 mm.
- an interbody device 10 may be constructed as one piece or assembled as a unit.
- overmolding processes including but not limited to injection and/or insert molding, may be used to couple an inner dampener 200 and outer shell materials.
- press-fitting, adhesives, mechanical fastening and like coupling means may be used.
- a mechanical spring or similarly compressible apparatus may be provided in place of or complimentary to an inner dampener 200 or compressible material.
- a molding method for manufacturing an interbody device 10 of the invention. Initially, outer shells 102 and 104 are each injection molded in a mold cavity. Next, shells 102 and 104 are placed into a different mold cavity for creating the inner dampener 200 . The dampener 200 is molded with and into the two shells 102 and 104 . Finally, the rim 210 is molded onto the three-piece molded assembly in yet another mold cavity. In such embodiment, the interbody device 10 is a four-piece, fully molded-together assembly.
- a trimming process may also be utilized where external molding support pegs (not shown) are also used to stabilize the outer shells 102 and 104 during manufacture.
- a peg may be added to the outside of each shell 102 and 104 on the center surface between openings 115 . Such peg holds each shell half in the mold cavity before and during the molding of the compliant inner dampener material. Such pegs may also hold the shell-dampener sub-assembly in the mold for the molding of the rim 210 .
- a support peg is 3.68 mm long with an elliptical shape and a middle cross-section area equivalent to a cylindrical peg of diameter of 1.04 mm. The supports pegs are trimmed off in the finishing of the interbody device 10 , including in embodiments where the outer surface of the interbody device 10 is made smooth.
Abstract
Description
Claims (20)
Priority Applications (2)
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US13/653,004 US9114021B2 (en) | 2007-06-08 | 2012-10-16 | Method for providing disc nucleus replacement in a spine |
US14/799,148 US9144502B1 (en) | 2007-06-08 | 2015-07-14 | Spinal interbody device |
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US12/134,946 US9005290B2 (en) | 2007-06-08 | 2008-06-06 | Spinal interbody device |
US12/726,112 US20100191333A1 (en) | 2007-06-08 | 2010-03-17 | Load-bearing spinal interbody device |
US13/653,004 US9114021B2 (en) | 2007-06-08 | 2012-10-16 | Method for providing disc nucleus replacement in a spine |
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US12/726,112 Division US20100191333A1 (en) | 2007-06-08 | 2010-03-17 | Load-bearing spinal interbody device |
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US14/799,148 Continuation US9144502B1 (en) | 2007-06-08 | 2015-07-14 | Spinal interbody device |
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US13/653,004 Active 2029-06-14 US9114021B2 (en) | 2007-06-08 | 2012-10-16 | Method for providing disc nucleus replacement in a spine |
US14/799,148 Active US9144502B1 (en) | 2007-06-08 | 2015-07-14 | Spinal interbody device |
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Publication number | Priority date | Publication date | Assignee | Title |
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US20100191333A1 (en) * | 2007-06-08 | 2010-07-29 | Morrison Iii Thomas J | Load-bearing spinal interbody device |
US9721262B2 (en) * | 2011-04-13 | 2017-08-01 | Douglas Krone | Systems and methods for providing time-sensitive communications of targeted advertisements to mobile devices |
US9427325B2 (en) * | 2013-07-26 | 2016-08-30 | Warsaw Orthopedic, Inc. | Interbody implant and method |
CN111529144B (en) * | 2018-06-12 | 2022-11-15 | 深圳市立心科学有限公司 | Self-adaptive intervertebral fusion device |
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Also Published As
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US20100191333A1 (en) | 2010-07-29 |
US20130041470A1 (en) | 2013-02-14 |
US9144502B1 (en) | 2015-09-29 |
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